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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Northwestern University | OTHER |
| University of New Mexico | OTHER |
| Children's National Research Institute |
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The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LGG | Experimental | LGG 10^10 cfu PO bid x 5 days |
|
| Placebo | Placebo Comparator | micro-crystalline cellulose PO bid x 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGG | Drug | LGG 10^10 cfu PO BID X 5 days |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Modified Vesikari Scale Score >=9 | This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores >=9 indicate moderate-severe gastroenteritis. Higher is worse. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With LGG Bacteremia | bacteremia caused by LGG | 1 month |
| Diarrhea Duration | diarrhea duration in hours after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Quayle, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Children's National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34596225 | Derived | Freedman SB, Finkelstein Y, Pang XL, Chui L, Tarr PI, VanBuren JM, Olsen C, Lee BE, Hall-Moore CA, Sapien R, O'Connell K, Levine AC, Poonai N, Roskind C, Schuh S, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Hurley K, Powell EC, Farion KJ, Schnadower D. Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):55-64. doi: 10.1093/cid/ciab876. | |
| 34183579 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactobacillus Rhamnosus GG | LGG 10^10 cfu PO bid x 5 days LGG: LGG 10^10 cfu PO BID X 5 days |
| FG001 | Placebo | micro-crystalline cellulose PO bid x 5 days micro-crystalline cellulose: 1 capsule PO bid x 5 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2017 |
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| OTHER |
| University of Utah | OTHER |
| Wayne State University | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Michigan | OTHER |
| Brown University | OTHER |
| University of California, Davis | OTHER |
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| micro-crystalline cellulose | Drug | 1 capsule PO bid x 5 days |
|
|
| 14 days |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
| Children's Hospital of New York | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| Schnadower D, O'Connell KJ, VanBuren JM, Vance C, Tarr PI, Schuh S, Hurley K, Rogers AJ, Poonai N, Roskind CG, Bhatt SR, Gouin S, Mahajan P, Olsen CS, Powell EC, Farion K, Sapien RE, Chun TH, Freedman SB; Pediatric Emergency Care Applied Research Network and Pediatric Emergency Research Canada. Association Between Diarrhea Duration and Severity and Probiotic Efficacy in Children With Acute Gastroenteritis. Am J Gastroenterol. 2021 Jul 1;116(7):1523-1532. doi: 10.14309/ajg.0000000000001295. |
| 34016656 | Derived | Freedman SB, Roskind CG, Schuh S, VanBuren JM, Norris JG, Tarr PI, Hurley K, Levine AC, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Powell EC, Farion KJ, Sapien R, O'Connell K, Poonai N, Schnadower D; Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Networks. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics. 2021 Jun;147(6):e2020030890. doi: 10.1542/peds.2020-030890. Epub 2021 May 20. |
| 33871616 | Derived | Poonai N, Powell EC, Schnadower D, Casper TC, Roskind CG, Olsen CS, Tarr PI, Mahajan P, Rogers AJ, Schuh S, Hurley KF, Gouin S, Vance C, Farion KJ, Sapien RE, O'Connell KJ, Levine AC, Bhatt S, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) and Pediatric Emergency Research Canada (PERC). Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Apr 1;4(4):e216433. doi: 10.1001/jamanetworkopen.2021.6433. |
| 33274370 | Derived | Schnadower D, Sapien RE, Casper TC, Vance C, Tarr PI, O'Connell KJ, Levine AC, Roskind CG, Rogers AJ, Bhatt SR, Mahajan P, Powell EC, Olsen CS, Gorelick MH, Dean JM, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis. J Nutr. 2021 Jan 4;151(1):65-72. doi: 10.1093/jn/nxaa313. |
| 30462938 | Derived | Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean JM, O'Connell KJ, Mahajan P, Levine AC, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Olsen CS, Metheney M, Dickey VP, Hall-Moore C, Freedman SB. Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children. N Engl J Med. 2018 Nov 22;379(21):2002-2014. doi: 10.1056/NEJMoa1802598. |
| 28947466 | Derived | Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean MJ, O'Connell KJ, Mahajan P, Chun TH, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Gao F, Freedman SB. Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol. BMJ Open. 2017 Sep 24;7(9):e018115. doi: 10.1136/bmjopen-2017-018115. |
| 24885220 | Derived | Freedman SB, Williamson-Urquhart S, Schuh S, Sherman PM, Farion KJ, Gouin S, Willan AR, Goeree R, Johnson DW, Black K, Schnadower D, Gorelick MH; Pediatric Emergency Research Canada (PERC) Gastroenteritis Study Group. Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial. Trials. 2014 May 14;15:170. doi: 10.1186/1745-6215-15-170. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus Rhamnosus GG | LGG 10^10 cfu PO bid x 5 days LGG: LGG 10^10 cfu PO BID X 5 days |
| BG001 | Placebo | micro-crystalline cellulose PO bid x 5 days micro-crystalline cellulose: 1 capsule PO bid x 5 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Median Modified Vesikari Scale score at presentation | The modified Vesikari scale is a validated global gastroenteritis severity scale that includes duration and severity of vomiting and diarrhea, maximum recorded temperature, unscheduled health care visits and types of treatment received. Scores range from 0 to 20, with higher scores indicating more severe disease). A score of 9 or greater is considred moderate to severe gastroenteritis | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Modified Vesikari Scale Score >=9 | This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores >=9 indicate moderate-severe gastroenteritis. Higher is worse. | Posted | Count of Participants | Participants | 14 days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With LGG Bacteremia | bacteremia caused by LGG | Posted | Count of Participants | Participants | 1 month |
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| Secondary | Diarrhea Duration | diarrhea duration in hours after randomization | Posted | Median | Inter-Quartile Range | hours | 14 days |
|
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35 days, long term follow up 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus Rhamnosus GG | LGG 10^10 cfu PO bid x 5 days LGG: LGG 10^10 cfu PO BID X 5 days | 0 | 483 | 8 | 483 | 55 | 483 |
| EG001 | Placebo | micro-crystalline cellulose PO bid x 5 days micro-crystalline cellulose: 1 capsule PO bid x 5 days | 0 | 488 | 13 | 488 | 49 | 488 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| seizure | Nervous system disorders | Systematic Assessment | febrile |
| |
| lethargy | Nervous system disorders | Systematic Assessment |
| ||
| lower respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| dehydration | Gastrointestinal disorders | Systematic Assessment |
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| metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| fever | General disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| other | Gastrointestinal disorders | Systematic Assessment |
| ||
| other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Schnadower | Cincinnati Children's Hospital Medical Center | 5138035526 | david.schnadower@cchmc.org |
| Jun 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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